MATULANE Drug Patent Profile

When do Matulane patents expire, and when can generic versions of Matulane launch?

Matulane is a drug marketed by Leadiant Biosci Inc and is included in one NDA.

The generic ingredient in MATULANE is procarbazine hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the procarbazine hydrochloride profile page.

Summary for MATULANE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	6
Patent Applications:	4,503
Drug Prices:	Drug price information for MATULANE
What excipients (inactive ingredients) are in MATULANE?	MATULANE excipients list
DailyMed Link:	MATULANE at DailyMed

See drug prices for MATULANE

Recent Clinical Trials for MATULANE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The Emmes Company, LLC	Phase 2
AIDS Malignancy Consortium	Phase 2
The EMMES Corporation	Phase 2

See all MATULANE clinical trials

Pharmacology for MATULANE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for MATULANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for MATULANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785-001	Approved Prior to Jan 1, 1982

International Patents for MATULANE

See the table below for patents covering MATULANE around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	120758
Denmark	120902
Belgium	618638
Malaysia	6500106	NOVEL HYDRAZINE DERIVATIVES AND A PROCESS FOR THE MANUFACTURE THEREOF
Sweden	354653
Cyprus	314	Novel hydrazine derivatives and a process for the manufacture thereof

MATULANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Matulane

Introduction

Matulane, also known by its generic name procarbazine, is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of stage III and stage IV Hodgkin lymphoma. This article delves into the market dynamics and financial trajectory of Matulane, highlighting its usage, pricing trends, and the broader implications for patients and the healthcare system.

Approval and Usage

Matulane is an anticancer drug and a member of the class of alkylating agents. It is often used as part of the MOPP chemotherapy regimen, which includes mechlorethamine, Oncovin (vincristine), and the corticosteroid prednisone[1].

Mechanism of Action

Matulane works by preventing the production of DNA and protein in cells, thereby blocking cell division. This mechanism is crucial in treating cancer cells that divide rapidly.

Administration

Matulane is administered orally in capsule form and is taken daily. The simplicity of its administration makes it a manageable part of a chemotherapy regimen.

Side Effects

While Matulane is effective, it comes with a range of side effects. Common side effects include nausea, vomiting, and low blood cell counts. Rare but serious side effects can include liver dysfunction, coma, vision changes, and secondary cancers[1].

Pricing Trends

One of the most significant aspects of Matulane's market dynamics is its pricing. The drug has been at the center of controversy due to its dramatic price increases. For instance, the price of Matulane increased by nearly 8,000% after the rights to the drug were acquired by a new company. This increase is a stark example of price gouging in the pharmaceutical industry, where the lack of competition allows companies to set exorbitant prices[2].

Impact of Price Increases

The extraordinary price increases of Matulane and similar drugs have profound financial implications for patients and the healthcare system. These increases contribute to what is known as "financial toxicity," which includes medical debt, loss of income, and psychological stress. Patients often face significant out-of-pocket expenses, which can be crippling, especially for those with limited financial resources[5].

Market Factors Contributing to Price Increases

Several market factors contribute to the extraordinary price increases seen with Matulane and other drugs. These include:

Lack of Competition

The absence of therapeutically equivalent drugs, both generics and other brand-name drugs, allows companies to raise prices without fear of losing market share. Patent protection and market exclusivity further limit competition, enabling companies to recoup their research and development costs and earn significant profits[4].

Corporate Consolidations

The consolidation among drug companies through mergers and acquisitions reduces the number of companies producing and marketing drugs. This leads to greater market domination by a few companies and less competition, which can drive up prices[4].

Repackaging and Reselling

Some drugs, including Matulane, are repackaged and resold in smaller quantities to healthcare providers. This practice can lead to higher prices due to the additional costs associated with repackaging and distribution[4].

Economic and Health Impact

Drug shortages and price increases, such as those seen with Matulane, have a significant economic and health impact. Shortages can affect patient care, and high prices can make essential medications unaffordable, leading to delayed or foregone treatments. This situation is particularly dire for off-patent drugs with low prices, which are often critical for treating rare or niche conditions[3].

Financial Implications for Patients and Healthcare Systems

The financial implications of high-cost medications like Matulane are far-reaching. Patients may face financial ruin due to the high costs of treatment, leading to medical debt and other financial hardships. Healthcare systems also bear the brunt of these costs, which can strain resources and impact the overall quality of care provided[5].

Industry Profits

Large pharmaceutical companies, including those that produce Matulane, have reported higher profits compared to non-pharmaceutical companies. The return on investment for cancer drugs, in particular, is substantial, with some studies showing an average return of $14.50 for every $1 spent on research and development[5].

Regulatory and Policy Considerations

The market dynamics surrounding Matulane highlight the need for regulatory and policy changes to address price gouging and ensure affordable access to essential medications. This includes measures to increase transparency in pricing, promote competition, and protect patients from exorbitant costs.

Key Takeaways

• Approval and Usage: Matulane is approved for treating stage III and IV Hodgkin lymphoma as part of the MOPP chemotherapy regimen.
• Pricing Trends: The drug has seen extraordinary price increases, contributing to financial toxicity for patients.
• Market Factors: Lack of competition, corporate consolidations, and repackaging practices contribute to high prices.
• Economic and Health Impact: High prices and shortages affect patient care and healthcare system resources.
• Financial Implications: Patients and healthcare systems face significant financial burdens due to high medication costs.
• Industry Profits: Pharmaceutical companies, including those producing Matulane, report high profits from cancer drugs.

FAQs

What is Matulane used for?

Matulane is used to treat stage III and stage IV Hodgkin lymphoma as part of the MOPP chemotherapy regimen.

How is Matulane administered?

Matulane is taken orally in capsule form and is administered daily.

What are the common side effects of Matulane?

Common side effects include nausea, vomiting, and low blood cell counts. Rare but serious side effects can include liver dysfunction, coma, and secondary cancers.

Why has the price of Matulane increased so dramatically?

The price of Matulane has increased dramatically due to a lack of competition, corporate consolidations, and the practice of repackaging and reselling the drug.

How do high drug prices affect patients and healthcare systems?

High drug prices contribute to financial toxicity for patients, leading to medical debt, loss of income, and psychological stress. Healthcare systems also face significant financial burdens due to these high costs.

What regulatory changes could help address the issue of high drug prices?

Regulatory changes could include increasing transparency in pricing, promoting competition, and protecting patients from exorbitant costs through measures such as price caps or subsidies.

Sources

1. MyLymphomaTeam: Matulane (Procarbazine) for Lymphoma.
2. Congress.gov: Are drug companies exploiting people with rare disease? Hearing.
3. Office of Health Economics: The Dynamics of Drug Shortages.
4. GAO: Brand-Name Prescription Drug Pricing.
5. Oxford Academic: Financial challenges of being on long-term, high-cost medications.